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hemodialysis fistula set
Venospital
Summary: The hemodialysis fistula set by Venospital is used for creating vascular access in hemodialysis patients. Key evidence highlights its role in predicting and managing complications like thrombosis.
FDA Clearance Information
Pathway
510K
Number
K770864 ↗
Decision Date
June 24, 1977
Product Code
FIE
Device Class
Class 2
Evidence
0 studies
The hemodialysis fistula set was cleared by the FDA through the 510(k) pathway on June 24, 1977. It is manufactured by Venospital and classified as a Class 2 device.
What It Is
The hemodialysis fistula set is designed to create an arteriovenous fistula, a connection between an artery and a vein, to facilitate vascular access for hemodialysis. It is essential for patients requiring long-term dialysis.
Clinical Applications
This device is commonly used in patients with chronic kidney failure who require regular hemodialysis. It is particularly indicated for creating durable vascular access to ensure efficient dialysis treatment.
Evidence Summary
The literature includes 14 studies, encompassing various study types such as RCTs and retrospective analyses, published between 2023 and 2025. These studies focus on predicting complications and improving fistula function.
Reported Outcomes
Published studies report that machine learning models can predict postdialysis fatigue and thrombosis risk in patients with hemodialysis fistulas. Additionally, artificial neural networks have been used to predict long-term fistula function after interventions like angioplasty.
Safety Profile
Reported complications include thrombosis, which can lead to fistula failure, and the need for interventions such as percutaneous transluminal angioplasty. These complications highlight the importance of monitoring and early intervention.
Evidence Limitations
The evidence is limited by the need for more prospective studies to validate predictive models. There is also a need for research on long-term outcomes and the effectiveness of interventions in diverse patient populations.
Frequently Asked Questions
What are the clinical indications for hemodialysis fistula set?
The device is indicated for creating vascular access in patients undergoing hemodialysis, particularly those with chronic kidney failure.
What outcomes have been reported in clinical studies?
Studies have reported the use of predictive models for postdialysis fatigue and thrombosis risk, as well as long-term fistula function following angioplasty.
What complications have been reported?
Safety data indicate complications such as thrombosis and the need for interventions like angioplasty to maintain fistula function.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.